Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Recruiting now · Not applicable

Conditions studied: Cardiovascular Complication, Bariatric Surgery Candidate

In brief

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.

Key facts

Study ID

NCT05531474

Run by

Population Health Research Institute

People needed

700

Starts

2020-11-02

Expected to finish

2027-07-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are \>55 years of age
• Age ≥18 years
• High-risk CVD, defined as the presence of any one of the following:
• High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)
• Left ventricular ejection fraction (LVEF) \< 40%
• Heart failure with preserved ejection fraction (LVEF \> 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \> 300 pg/ml or BNP \> 100 pg/ml in the past 12 months
• Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
• History of any stroke
• Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)

You may not qualify if…

• Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
• Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
• Pregnancy
• Contraindication to bariatric surgery
• Prior bariatric surgery, other than gastric banding
• Life expectancy \<2 years from non-cardiovascular causes
• Inability to provide informed consent

Where it is running

• Hamilton Health Sciences — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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